--- a +++ b/clusters/9knumclustersv2/clust_1382.txt @@ -0,0 +1,28 @@ +Subjects treated, or anticipated to be treated, with a calcineurin inhibitor (because concomitant use of sirolimus and a calcineurin inhibitor increases the risk of calcineurin inhibitor-induced hemolytic uremic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy [HUS/TTP/TMA]). +Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) +History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura +Platelet >= ,/mm^ (unless impairment due to idiopathic thrombocytopenic purpura [ITP]) +Autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requires > mg daily (QD) of prednisone (or equivalent) to maintain hemoglobin >. g/dL or platelets >, ?L without transfusion support +Uncontrolled autoimmune hemolytic anemia (Hgb < g/deciliter) or idiopathic thrombocytopenic purpura (< ,/l) +History of autoimmune disorder (e.g. hepatitis; idiopathic thrombocytopenic purpura [ITP]; scleroderma; severe psoriasis affecting > % of the body, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory drugs [NSAID] for management) +Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. +Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. +Patients with active or uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) are excluded; patients who have transfusion-dependent thrombocytopenia or bleeding/coagulation disorders that may increase the risk of life-threatening bleeding are excluded +Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia +Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment +History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura +History of thrombotic microangiopathy, hemolytic-uremic syndrome, or thrombotic thrombocytopenic purpura +Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. +Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requiring > mg once daily (QD) of prednisone (or equivalent) to maintain hemoglobin > . g/dL or platelets > , ?L without transfusion support +History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura. +Active, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) +Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP) +Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within year of first dose) +History of microangiopathic hemolysis, thrombotic thrombocytopenic purpura (TTP) or hemolytic-uremic syndrome (HUS) +Underlying renal disease with a high risk of disease recurrence in the transplanted kidney, including:\r\n* Focal segmental glomerulosclerosis (FSGS)\r\n* Type I or II membranoproliferative glomerulonephritis\r\n* Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura +Subjects enrolled into the previously untreated subject cohort must also meet all of the following criteria: No prior treatment for CLL (prior corticosteroid immunosuppression treatment for autoimmune hemolytic anaemia and idiopathic thrombocytopenic purpura (ITP) is permitted); Be considered inappropriate for fludarabine-based therapy for reasons that include, but are not limited to, advanced age or presence of co-morbidities. +Active autoimmune hemolytic anaemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) requiring corticosteroid therapy greater than mg prednisone (or equivalent) or chemotherapy. +Active, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy +Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS) +History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura +Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP)